Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should be paramount. The principles of data management are simple and well-founded. However, the application of these principles needs careful consideration, depending on various scenarios and the size of the organization. When implementing data management for your trial, it is critical to plan ahead and fully understand all the steps and activities involved. Fortunately, both strategic and tactical opportunities are available to help sponsors successfully implement a data management strategy, and ensure quality and simplicity in data collection to enable subsequent analysis. In this ebook, our experienced global data management team outlines some considerations to help sponsors navigate key decisions that need to be made throughout trial implementation.
We discuss the importance of establishing clear data standards for both operational efficiency and regulatory purposes; the practicalities of selecting an electronic data capture system; how to ensure your data is processed quickly and to a high level of quality; and managing a close alignment between data management and statistics functions.